Back to resultsStudy of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD
Primary Purpose
Autism Spectrum Disorder
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cariprazine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Cariprazine, VRAYLAR, AGN-241780
Eligibility Criteria
Inclusion Criteria:
- Participants at the time of screening must have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ASD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime (K-SADS-PL) administered at screening (Visit 1) by a trained clinician.
- Participants must have an Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) subscale score ≥ 18 (Visits 1 and 2).
- Participants must have a Clinical Global Impressions - Severity - Irritability (CGI-S Irritability) score ≥ 4 at screening (Visits 1 and 2).
Exclusion Criteria:
- Participants with diagnosis of intellectual disability (Intelligence quotient < 70).
- History of any current psychiatric diagnosis other than ASD (including those with current intellectual development disability)
Sites / Locations
- Advanced Research Center /ID# 245049Recruiting
- Sun Valley Research Center /ID# 243133Recruiting
- CHOC Children's Hospital /ID# 245577Recruiting
- Pacific Clinical Research Management Group /ID# 243019Recruiting
- D&H Doral Research Center-Doral /ID# 255457Recruiting
- Sarkis Clinical Trials /ID# 242868Recruiting
- Advanced Research Institute of Miami /ID# 243179Recruiting
- Sandhill Research LLC /ID# 245079Recruiting
- Axcess Medical Research /ID# 244952
- K2 Medical Research /ID# 248694Recruiting
- G+C Research Group, LLC /ID# 252016Recruiting
- Medical Research Group of Central Florida /ID# 243170Recruiting
- APG Research, LLC /ID# 243130Recruiting
- Nona Pediatric Center /ID# 245078Recruiting
- Asclepes Research Centers - Spring Hill /ID# 248682Recruiting
- D&H Tamarac Research Center /ID# 250436Recruiting
- Atlanta Center for Medical Research /ID# 243124Recruiting
- Atlanta Behavioral Research, LLC /ID# 243082Recruiting
- Dr. Hosneara, M.D. LLC /ID# 252129Recruiting
- New Dawn Psychiatric Services PLLC /ID# 243697Recruiting
- Quest Therapeutics of Avon Lake /ID# 252013Recruiting
- CincyScience /ID# 242993Recruiting
- BioBehavioral Research of Austin /ID# 255460Recruiting
- Relaro Medical Trials /ID# 243126Recruiting
- Cedar Health Research /ID# 248683Recruiting
- AIM Trials /ID# 243120Recruiting
- Family Psychiatry of The Woodlands /ID# 242867Recruiting
- Advanced Research Institute - Ridgeline /ID# 243098Recruiting
- Core Clinical Research /ID# 243084Recruiting
- Dr. Samuel Sanchez PSC /ID# 245739Recruiting
- GCM Medical Group PSC /ID# 245735Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cariprazine
Placebo
Arm Description
Participants will receive age-and weight dependent flexible doses of cariprazine once daily for 8-weeks.
Participants will receive placebo once daily for 8-weeks.
Outcomes
Primary Outcome Measures
Change from Baseline in Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) Subscale Score
The Aberrant Behavior Checklist (ABC) - Community version is a 58-item, caregiver-rated scale designed to measure inappropriate and maladaptive behavior of people with developmental disabilities (including intellectual disability and ASD). The ABC has 5 subscales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactivity and Inappropriate Speech). The caregiver rates the child's behavior from 0=not at all a problem to 3= the problem is severe in degree. The range for Irritability is 0 to 45. Higher scores indicate greater severity.
Secondary Outcome Measures
Percentage of Participants with responder status of "Very Much Improved" or "Much Improved" on the Clinical Global Impression- Change Irritability (CGI-C Irritability) Scale
The Clinical Global Impression - Change-Irritability (CGI-C Irritability) is a single-item rating scale that assesses change in the severity of a participant's irritability from the clinician's perspective. The CGI-C Irritability 7-point graded response scale (1 = "Very much improved," 2 = "Much improved," 3 = "Minimally improved," 4 = "No change," 5 = "Minimally worse," 6 = "Much worse," or 7 = "Very much worse").
Change from Baseline in Parent-Rated Anxiety Scale for Youth with Autism Spectrum Disorder (PRAS-ASD) Total Score
PRAS-ASD is a 25-item caregiver-reported measure of anxiety in participants aged 3 to 17 with ASD. All items use a 4-point response scale: 0 = "None (not present);" 1 = "Mild (present sometimes, not a real problem);" 2 = "Moderate (often present and a problem);" 3 = "Severe (very frequent and a major problem)." Total score ranges from 0 to 75, with higher scores indicating greater severity of anxiety.
Change from Baseline in Caregiver Strain Questionnaire Short Form 7-Item (CGSQ SF-7) total score
CGSQ SF-7 is a caregiver-reported 7-item measure of self-reported strain that focuses on the impact of caring for a child with emotional and behavioral problems. Responses are scored on a 5-point scale (1 = "Not at all," 2 = "A little;" 3 = "Somewhat;" 4 = "Quite a bit;" and 5 "Very much") with higher scores indicating greater caregiver strain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05439616
Brief Title
Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD
Official Title
An 8-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Phase 3 Study of the Efficacy and Safety of Cariprazine in the Treatment of Pediatric Subjects (5 to 17 Years of Age) With Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
October 26, 2024 (Anticipated)
Study Completion Date
January 18, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Autism spectrum disorder (ASD) consists of deficits in social, communication, and cognitive development, repetitive and stereotypic behaviors. Many ASD patients show notably high levels of irritability, including verbal and physical aggression, self injury, and/or property destruction. Autistic infants tend to avoid eye contact and show little interest in others. This study will assess how safe and effective cariprazine is in treating pediatric participants (5 to 17 years of age) with ASD. Adverse events and change in disease activity will be assessed.
Cariprazine is an investigational drug being developed for the treatment of irritability due to ASD. This study is double-blinded means that neither the participants nor the study doctors will know who will be given cariprazine and who will be given placebo (does not contain treatment drug). Study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 152 participants diagnosed with ASD will be enrolled in approximately 50 sites globally.
Participants will receive oral capsules or oral solution of cariprazine or placebo once daily for 8-weeks and will undergo a 12-week safety follow-up period.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, Cariprazine, VRAYLAR, AGN-241780
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cariprazine
Arm Type
Experimental
Arm Description
Participants will receive age-and weight dependent flexible doses of cariprazine once daily for 8-weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo once daily for 8-weeks.
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Other Intervention Name(s)
VRAYLAR, AGN-241780
Intervention Description
Oral Capsules or Oral Solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral capsules or Oral Solution
Primary Outcome Measure Information:
Title
Change from Baseline in Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) Subscale Score
Description
The Aberrant Behavior Checklist (ABC) - Community version is a 58-item, caregiver-rated scale designed to measure inappropriate and maladaptive behavior of people with developmental disabilities (including intellectual disability and ASD). The ABC has 5 subscales (Irritability, Social Withdrawal, Stereotypic Behavior, Hyperactivity and Inappropriate Speech). The caregiver rates the child's behavior from 0=not at all a problem to 3= the problem is severe in degree. The range for Irritability is 0 to 45. Higher scores indicate greater severity.
Time Frame
Baseline (Week 0) to Week 8
Secondary Outcome Measure Information:
Title
Percentage of Participants with responder status of "Very Much Improved" or "Much Improved" on the Clinical Global Impression- Change Irritability (CGI-C Irritability) Scale
Description
The Clinical Global Impression - Change-Irritability (CGI-C Irritability) is a single-item rating scale that assesses change in the severity of a participant's irritability from the clinician's perspective. The CGI-C Irritability 7-point graded response scale (1 = "Very much improved," 2 = "Much improved," 3 = "Minimally improved," 4 = "No change," 5 = "Minimally worse," 6 = "Much worse," or 7 = "Very much worse").
Time Frame
Week 8
Title
Change from Baseline in Parent-Rated Anxiety Scale for Youth with Autism Spectrum Disorder (PRAS-ASD) Total Score
Description
PRAS-ASD is a 25-item caregiver-reported measure of anxiety in participants aged 3 to 17 with ASD. All items use a 4-point response scale: 0 = "None (not present);" 1 = "Mild (present sometimes, not a real problem);" 2 = "Moderate (often present and a problem);" 3 = "Severe (very frequent and a major problem)." Total score ranges from 0 to 75, with higher scores indicating greater severity of anxiety.
Time Frame
Baseline (Week 0) to Week 8
Title
Change from Baseline in Caregiver Strain Questionnaire Short Form 7-Item (CGSQ SF-7) total score
Description
CGSQ SF-7 is a caregiver-reported 7-item measure of self-reported strain that focuses on the impact of caring for a child with emotional and behavioral problems. Responses are scored on a 5-point scale (1 = "Not at all," 2 = "A little;" 3 = "Somewhat;" 4 = "Quite a bit;" and 5 "Very much") with higher scores indicating greater caregiver strain.
Time Frame
Baseline (Week 0) to Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants at the time of screening must have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ASD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime (K-SADS-PL) administered at screening (Visit 1) by a trained clinician.
Participants must have an Aberrant Behavior Checklist, 2nd edition - Community Version - Irritability (ABC-I) subscale score ≥ 18 (Visits 1 and 2).
Participants must have a Clinical Global Impressions - Severity - Irritability (CGI-S Irritability) score ≥ 4 at screening (Visits 1 and 2).
Exclusion Criteria:
Participants with diagnosis of intellectual disability (Intelligence quotient < 25).
No history of major depressive disorder, bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition, as excluded by administration of Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime (K-SADS-PL).
History of ASD that is associated with Rett Disorder, Fragile-X Syndrome, or Childhood Disintegrative Disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Research Center /ID# 245049
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Recruiting
Facility Name
Sun Valley Research Center /ID# 243133
City
Imperial
State/Province
California
ZIP/Postal Code
92251-9401
Country
United States
Individual Site Status
Recruiting
Facility Name
CHOC Children's Hospital /ID# 245577
City
Orange
State/Province
California
ZIP/Postal Code
92868-4203
Country
United States
Individual Site Status
Recruiting
Facility Name
Pacific Clinical Research Management Group /ID# 243019
City
Upland
State/Province
California
ZIP/Postal Code
91786-3676
Country
United States
Individual Site Status
Recruiting
Facility Name
D&H Doral Research Center-Doral /ID# 255457
City
Doral
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarkis Clinical Trials /ID# 242868
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Research Institute of Miami /ID# 243179
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030-4613
Country
United States
Individual Site Status
Recruiting
Facility Name
Sandhill Research LLC /ID# 245079
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Individual Site Status
Recruiting
Facility Name
Axcess Medical Research /ID# 244952
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Individual Site Status
Completed
Facility Name
K2 Medical Research /ID# 248694
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751-5669
Country
United States
Individual Site Status
Recruiting
Facility Name
G+C Research Group, LLC /ID# 252016
City
Miami
State/Province
Florida
ZIP/Postal Code
33126-2018
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
(305) 283-6254
Facility Name
Medical Research Group of Central Florida /ID# 243170
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Individual Site Status
Recruiting
Facility Name
APG Research, LLC /ID# 243130
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Name
Nona Pediatric Center /ID# 245078
City
Orlando
State/Province
Florida
ZIP/Postal Code
32829-8070
Country
United States
Individual Site Status
Recruiting
Facility Name
Asclepes Research Centers - Spring Hill /ID# 248682
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609-5692
Country
United States
Individual Site Status
Recruiting
Facility Name
D&H Tamarac Research Center /ID# 250436
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321-2979
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta Center for Medical Research /ID# 243124
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta Behavioral Research, LLC /ID# 243082
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr. Hosneara, M.D. LLC /ID# 252129
City
Jackson Heights
State/Province
New York
ZIP/Postal Code
11372-3922
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
+1 (347) 754-8380
Facility Name
New Dawn Psychiatric Services PLLC /ID# 243697
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501-1603
Country
United States
Individual Site Status
Recruiting
Facility Name
Quest Therapeutics of Avon Lake /ID# 252013
City
Avon Lake
State/Province
Ohio
ZIP/Postal Code
44012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
4405066907
Facility Name
CincyScience /ID# 242993
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Individual Site Status
Recruiting
Facility Name
BioBehavioral Research of Austin /ID# 255460
City
Austin
State/Province
Texas
ZIP/Postal Code
78759-5290
Country
United States
Individual Site Status
Recruiting
Facility Name
Relaro Medical Trials /ID# 243126
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedar Health Research /ID# 248683
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251-2202
Country
United States
Individual Site Status
Recruiting
Facility Name
AIM Trials /ID# 243120
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Name
Family Psychiatry of The Woodlands /ID# 242867
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Research Institute - Ridgeline /ID# 243098
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405-6779
Country
United States
Individual Site Status
Recruiting
Facility Name
Core Clinical Research /ID# 243084
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr. Samuel Sanchez PSC /ID# 245739
City
Caguas
ZIP/Postal Code
00727
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
GCM Medical Group PSC /ID# 245735
City
San Juan
ZIP/Postal Code
00917-3104
Country
Puerto Rico
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M21-465
Description
Related Info
Learn more about this trial
Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD
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